A Randomized Controlled Trial Evaluating Dental Implant Placement in the Anterior Esthetic Zone Using Two Guided Bone Regeneration Techniques: Prefabricated CAD/CAM Zirconia Membrane vs. Contour Augmentation.

Not Applicable

Active, not recruiting

• Conditions: Alveolar Ridge Augmentation, Dental Implants; Alveolar Ridge Deficiency in the Anterior Esthetic Zone

• Registration Number: NCT06987149
• Lead Sponsor: Mohammed Mashhout Eisa Anas

Brief Summary

This clinical trial aims to compare two guided bone regeneration (GBR) techniques in patients with horizontal ridge deficiency in the anterior esthetic region. Specifically, it evaluates the use of a prefabricated CAD/CAM zirconia membrane versus conventional contour augmentation performed simultaneously with dental implant placement. The study includes male and female patients aged 20 to 50 years who are in good general health, maintain adequate oral hygiene, and present with a Class I ridge defect as per Seibert's classification.

The primary objective is to determine whether the customized zirconia membrane provides equivalent clinical and radiographic outcomes in terms of bone gain and soft tissue healing compared to the contour augmentation technique. Participants will also report their postoperative discomfort and overall satisfaction using a 100-point visual analog scale (VAS), recorded at multiple time points: 1, 6, and 12 hours, as well as 1, 3, 7, and 15 days postoperatively.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-11-01
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients of both genders within the age range of 20-50 years.
• Patients with good general health and adequate oral hygiene practices.
• Stable periodontal condition and favorable soft tissue profile.
• Alveolar ridge that has a Class I defect according to Seibert's classification of ridge defects.

Exclusion Criteria

• Patients with medical conditions or systemic diseases precluding periodontal surgery or hampering wound healing (e.g., uncontrolled diabetes mellitus or metabolic bone disorders).
• Patients subjected to irradiation in the head and neck area.
• Patients with a history of taking any medications in the previous 6 months that may interfere with periodontal tissue health or healing.
• Patients have poor oral hygiene and motivation.
• Patients with active periodontitis or acute infection in the area intended for implant placement.
• Females who are pregnant or trying to conceive, and nursing mothers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Alveolar bone gain in millimetres (mm) in the edentulous alveolar ridge	Six months	Assessment of the horizontal and vertical bone gain in millimetres (mm) in the edentulous alveolar ridge from baseline (implant placement and grafting) to six months after surgery.

Secondary Outcome Measures

Name	Time	Method
Periodontal Soft Tissue Healing (Modified Wound Healing Index - MWHI)	Baseline (day of surgery), and postoperatively at 4, 8, 12, and 24 weeks	Evaluation of periodontal soft tissue healing around the surgical site using the Modified Wound Healing Index (MWHI) developed by Huang et al. This index categorizes wound healing based on clinical parameters including mucosal edema, erythema, graft exposure, and presence of suppuration. Scores range from 1 to 3: Score 1 - Uneventful Healing: No or minimal mucosal edema or erythema, with no suppuration or graft exposure.; Score 2 - Normal Healing: Slight to moderate mucosal edema, erythema, and/or graft exposure, but without suppuration.; Score 3 - Poor Healing: Significant mucosal edema, erythema, graft exposure, and presence of suppuration.
Patient-Reported Postoperative Discomfort and Satisfaction	1 hour, 6 hours, 12 hours, and 1, 3, 7, 15 days postoperatively	Assessment of postoperative discomfort and overall patient satisfaction using a 100-point Visual Analog Scale (VAS). Participants will self-report their pain levels and satisfaction at multiple postoperative time points: 1, 6, and 12 hours, as well as 1, 3, 7, and 15 days after surgery.
Membrane-Related Operative Time	Recorded during the implant placement and bone regeneration surgery	Measurement of the time (in minutes) required to place the guided bone regeneration membrane during the surgical procedure. This will assess the efficiency and ease of use of the prefabricated CAD/CAM zirconia membrane compared to conventional contour augmentation.

Trial Locations

Locations (1)

Faculty of dentistry- Tanta university; 🇪🇬 Tanta, Gharbia, Egypt